Skip to content

Veno-arterial CO2 Pressure Difference to Arterio-venous O2 Difference Ratio & Blood Lactate Levels Are Predictors of Postoperative Outcome in Whipple Procedures

Veno-arterial CO2 Pressure Difference to Arterio-venous O2 Difference Ratio & Blood Lactate Levels Are Predictors of Postoperative Outcome in Whipple Procedures

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07306845
Enrollment
120
Registered
2025-12-29
Start date
2025-12-25
Completion date
2026-06-25
Last updated
2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Outcome, Whipple Procedures

Keywords

CO2 Pressure Difference, O2 Difference, Blood Lactate

Brief summary

Whipple surgery is a complex abdominal procedure associated with a high risk of hemodynamic instability and splanchnic hypoperfusion leading to anastomotic leaks, delayed gastric emptying, and organ dysfunction Traditional markers (e.g., MAP, mixed venous oxygen saturation \[SvO₂\], lactate) are indirect, invasive and often delayed. CO₂-derived variables (e.g., venous-to-arterial CO₂ gap \[ΔCO₂\], tissue CO₂ \[PtCO₂\], end-tidal CO₂ \[EtCO₂\] changes) provide earlier and more sensitive signs of microcirculatory dysfunction.

Detailed description

Whipple surgery is a complex abdominal procedure associated with a high risk of hemodynamic instability and splanchnic hypoperfusion leading to anastomotic leaks, delayed gastric emptying, and organ dysfunction Traditional markers (e.g., MAP, mixed venous oxygen saturation \[SvO₂\], lactate) are indirect, invasive and often delayed. CO₂-derived variables (e.g., venous-to-arterial CO₂ gap \[ΔCO₂\], tissue CO₂ \[PtCO₂\], end-tidal CO₂ \[EtCO₂\] changes) provide earlier and more sensitive signs of microcirculatory dysfunction. The present study investigate the hypothesis that simultaneous measurement of Venous-to-Arterial CO₂ Gap Indexed to Oxygen Content Difference (Pv-aCO₂/Ca-vO₂ Ratio & blood lactate may provide one or more early markers for post-operative adverse outcome in Whipple procedure

Interventions

OTHERpredictors of postoperative outcome in Whipple Procedures

CO₂-Derived Parameters & Lactate as Predictors of Postoperative outcome in Whipple Procedures and the occurrence of complications

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults (\>18 years) undergoing open Whipple procedure under general anesthesia * Invasive monitoring (arterial line and central venous catheter) * Informed written consent

Exclusion criteria

* Emergency surgery. * Preoperative septic shock or hemodynamic instability. * severe pre-existing \*\*cardiopulmonary disease (e.g., severe COPD, heart failure).

Design outcomes

Primary

MeasureTime frameDescription
Venous-to-Arterial CO₂ Gap (Pv-aCO₂ = PvCO₂ - PaCO₂)T0 baseline (After induction of anesthesia) T1 intraoperative (After major vessel dissection) T2 intraoperative (Immediately post-pancreatic resection) T3 intraoperative (After GIT anastomosis) T4 End of surgery T5 postoperative (2 hours)Measured via arterial and central venous blood gases sampling throughout the Whipple procedure
Arterial-Venous oxygen content difference (Ca-vO₂ = CaO₂ - CvO₂)T0 baseline (After induction of anesthesia) T1 intraoperative (After major vessel dissection) T2 intraoperative (Immediately post-pancreatic resection) T3 intraoperative (After GIT anastomosis) T4 End of surgery T5 postoperative (2 hours) in ICUMeasured via arterial and central venous blood gases
Veno-arterial CO2 Pressure Difference to Arterio-venous O2 Difference Ratio (Pv-aCO₂/Ca-vO₂ ratio )T0 baseline (After induction of anesthesia) T1 intraoperative (After major vessel dissection) T2 intraoperative (Immediately post-pancreatic resection) T3 intraoperative (After GIT anastomosis) T4 End of surgery T5 postoperative (2 hours) in ICUcalculated by dividing the previous 2 measurements (Pv-aCO₂/Ca-vO₂ )

Secondary

MeasureTime frameDescription
Occurrence of post-operative complicationspostoperatively within 1 month30-day mortality
Traditional Perfusion Markers :LactateT0 baseline (After induction of anesthesia) T1 intraoperative (After major vessel dissection) T2 intraoperative (Immediately post-pancreatic resection) T3 intraoperative (After GIT anastomosis) T4 End of surgery T5 postoperative (2 hours) in ICUMeasured via arterial blood gases sampling
occurrence of postoperative complication as acute liver dysfunctionpostoperatively within 3 daysPostoperative liver dysfunction is defined as new impairment in liver function occurring after surgery, typically within the first 48-72 hours, manifested by one or more of the following: 1.Hyperbilirubinemia Total bilirubin \> 2 mg/dL (34 µmol/L) OR a rise \> 50% from baseline, 2.Elevated Liver Enzymes Increase in AST or ALT greater than 2-3 × upper limit of normal (ULN) Coagulopathy INR ≥ 1.5
occurrence of Organ dysfunction (AKI)postoperatively within 3 days in ICUOrgan dysfunction (AKI), a patient is considered to have AKI postoperatively if any one of the following occurs: Increase in serum creatinine ≥ 0.3 mg/dL (≥ 26.5 µmol/L) within 48 hours, OR Increase in serum creatinine to ≥ 1.5 times baseline, OR Urine output \< 0.5 mL/kg/hr for ≥ 6 hours.
occurrence of Postoperative complicationswithin 3 days in ICU for complications, 30 days postoperatively for mortality• Anastomotic leak rate (pancreaticojejunostomy, hepaticojejunostomy), Delayed gastric emptying (DGE), Postoperative pancreatic fistula (POPF),
ICU length of staypostoperative 3 daystotal ICU stay ( days)

Contacts

Primary ContactAlaa Anwar Abdelrahman, MD
A_Aly16@alexmed.edu.eg00201281218573

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026